All over the world, patients value our expertise in human genetic testing

CENTOGENE holds numerous international quality accreditations, demonstrating our commitment to excellence across all our services.

  1. Accreditation

Quality driven to achieve scientific excellence

CENTOGENE follows the strictest quality criteria in an effort to meet our customer’s requirements in clinical diagnostics, clinical trial services and research and development. This is supported by CENTOGENE’s multi discipline quality management system (QMS), which has been recognized by our CAP, CLIA and ISO 15189 certifications. CENTOGENE’s QMS integrates into every aspect of our operations, spanning from data integrity and privacy, patient safety, responsibility to scientific research and innovations.

Furthermore, as a full service company - we follow applicable and market-standard good laboratory practice (GLP) and good manufacturing practice (GMP) guidelines and have been found compliant in this regard in several audits by our customers. 

CENTOGENE holds the following accreditations and certifications

We continually participate in the international external proficiency testing schemes of the European Molecular Biology Quality Network (EMQN), CAP (College of American Pathologists) to ensure technical,  medical competency and proficiency.


College of American Pathologists

CENTOGENE is CAP accredited # 8005167


Centers for Medicare and Medicaid Services

CENTOGENE received the certificate of accreditation CLIA registered # 99D2049715


Illumina Propel Certification for Core and Service Labs

CENTOGENE has successfully completed certification for HiSeq 4000 System, NextSeq System and MiSeq System provided by Illumina Inc.

College of American Pathologists

CENTOGENE is is CAP accreditated CAP ISO 15189

  • College of American Pathologists CAP ISO15189

    Download

State of California Department of Public Health

CENTOGENE is licensed to provide laboratory services in California


State of Florida CLINICAL LABORATORY

CENTOGENE AG has completed the application and approval of the Florida State license for Clinical Laboratory Services- High Complexity Testing.


Pennsylvania Department of Health

CENTOGENE is licensed to provide laboratory services in Pennsylvania

  • Clinical laboratory permit Pennsylvania

    Download

Australian Government Department of Health

CENTOGENE received the Australian Register of Therapeutic Goods Certificate

  • Australian Register of Therapeutic Goods Certificate

    Download

Maryland Department of Health and Mental Hygiene

CENTOGENE received the medical laboratory permit for the performance of medical laboratory tests in molecular genetics.


State of Rhode Island and Providence Plantations Department of Health

CENTOGENE is authorized to conduct and maintain an Out of State Clinical Laboratory in conformity with RIGL C23-16.2.

  • Clinical laboratory license Rhode Island

    Download

Ministry of Food and Drug Safety

CENTOGENE has received Certificate of GMP from the Ministry of Drug and Safety in South Korea


Centers for Medicare and Medicaid Services (CMS)

CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971